Actively Recruiting
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury
Led by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Updated on 2026-03-02
20
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups. Both groups will receive eight-weeks of individualized gait training. We will measure adverse events, including pain and skin irritation, to determine safety as the primary outcome. Hypothesis 1: Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS. Hypothesis 2: TSCS is feasible based on compliance to session interventions and long-term adherence to the protocol. Additionally, we will collect data on effort during sessions of both participant and therapist. We anticipate that the participants will report less effort in the experimental condition, as compared to the control and therapists will report equal effort across conditions. Aim 2: Determine the neurophysiologic impact of TSCS within a single session. We hypothesize that participants will demonstrate increased volitional muscle activity and strength with TSCS as compared to sham stimulation. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC), across multiple time points. Changes in EMG activity will indicate change in central excitability in response to stimulation. Aim 3: Exploratory measurement of TSCS and gait training on walking function. We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation. In addition to outcomes defined above, participants will be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test. Data collected as part of this aim will elucidate trends in responder qualities and timeline of changes to inform future studies.
CONDITIONS
Official Title
Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 to 16 years
- At least 6 months post spinal cord injury
- Non-progressive spinal cord injury
- Classified as AIS C or D (incomplete injury with specific muscle strength criteria)
- Neurologic level above T10
- Able to tolerate standing upright for more than 30 minutes
- Able to move one lower leg forward while standing (bracing and assistive devices allowed)
- Medically stable with no hospitalizations in the last 3 months
- Able to comply with the International Standards for neurological and functional Classification of Spinal Cord Injury exam
You will not qualify if you...
- Progressive spinal cord injury or disease such as Multiple Sclerosis or Acute Disseminated Encephalomyelitis
- Active wounds
- Limited range of motion affecting gait training
- Presence of cardiac pacemaker or defibrillator
- Active cancer diagnosis
- Absence of lower extremity reflexes
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
S
Shannon M Inches
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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